Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 36
- Latest Decision
- 2019-10-24
Clearances · page 33 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | PLR | Class II | 2019-10-24 |
| K191358 | Trident II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH | Class II | 2019-10-24 |
| K192678 | Genesys Spine Binary® Lumbar Plate System | Genesys Spine | KWQ | Class II | 2019-10-24 |
| K191812 | ADI Cervical Interbody Fusion Device | Additive Device, Inc. (Adi) D/B/A Restor3D | ODP | Class II | 2019-10-24 |
| K190349 | MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. | MQP | Class II | 2019-10-24 |
| K192314 | RESONATE Anterior Cervical Plate System | Globus Medical, Inc. | KWQ | Class II | 2019-10-23 |
| K191814 | Alliance Glenoid | Zimmer, Inc. | KWS | Class II | 2019-10-23 |
| K192084 | Madison Total Knee System | Implanet, S.A. | JWH | Class II | 2019-10-22 |
| K192268 | Europa Pedicle Screw System | MiRus, LLC | NKB | Class II | 2019-10-22 |
| K190890 | Exactech Alteon Modular Dual Mobility (MDM) System | Exactech, Inc. | LZO | Class II | 2019-10-22 |
| K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | KWQ | Class II | 2019-10-22 |
| K190136 | Fusion Silastic System | Fusion Orthopedics, LLC | KWH | Class II | 2019-10-21 |
| K192532 | Arthrex SwiveLock Anchor | Arthrex, Inc. | MAI | Class II | 2019-10-19 |
| K191513 | Altapore Shape | Baxter Healthcare Corporation | MQV | Class II | 2019-10-19 |
| K190636 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | NKB | Class II | 2019-10-19 |
| K192760 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2019-10-18 |
| K192441 | Arthrex SwiveLock Anchors | Arthrex, Inc. | MAI | Class II | 2019-10-17 |
| K192316 | Matrix HA PEEK Cervical Implant System | Sapphire Medical Group | ODP | Class II | 2019-10-17 |
| K190953 | Arthrex Minimally Invasive Ankle Fusion Plate | Arthrex, Inc. | HRS | Class II | 2019-10-16 |
| K190486 | Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt. , Ltd. | KTT | Class II | 2019-10-16 |
| K191771 | SECURE Screw | A.M. Surgical, Inc. | HWC | Class II | 2019-10-16 |
| K191326 | Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module | Arthrex, Inc. | HRS | Class II | 2019-10-15 |
| K192434 | DualX Lumbar Intervertebral Body Fusion Device | Amplify Surgical, Inc. | MAX | Class II | 2019-10-15 |
| K192312 | Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH | HSB | Class II | 2019-10-11 |
| K192214 | CarboClear VBR System | CarboFix Orthopedics , Ltd. | MQP | Class II | 2019-10-11 |
| K191822 | Nano FortiCore, FortiCore | Nanovis, LLC | ODP | Class II | 2019-10-11 |
| K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | MBF | Class II | 2019-10-10 |
| K192465 | DigiFix Sterile Kit | Virak Orthopedics, LLC | JEC | Class II | 2019-10-10 |
| K191596 | Arcadia Balloon Catheter | Merit Medical Systems, Inc. | HRX | Class II | 2019-10-09 |
| K190321 | Pediatric Nailing PlatformFemur | OrthoPediatrics Corp. | HSB | Class II | 2019-10-09 |
| K192208 | CORNICE Cervical Spacer System | Legend Spine Technologies | ODP | Class II | 2019-10-09 |
| K191783 | Parcus Synd-EZ Ti | Parcus Medical, LLC | MBI | Class II | 2019-10-09 |
| K192206 | 32mm Glenosphere and Humeral Cup | Fx Shoulder USA, Inc. | PHX | Class II | 2019-10-08 |
| K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | HSX | Class II | 2019-10-08 |
| K191779 | Attune Revision LPS Inserts | Depuy(Ireland) | KRO | Class II | 2019-10-08 |
| K191632 | PROFEMUR TL2 Stems | Microport Orthopedics, Inc. | LZO | Class II | 2019-10-07 |
| K192428 | AFX Femoral Implant with Inserter | Cayenne Medical | MBI | Class II | 2019-10-05 |
| K192448 | Delta Xtend Revers Shoulder System | Depuy(Ireland) | PHX | Class II | 2019-10-04 |
| K190179 | SAHARA Stabilization System | K2m, Inc. | OVD | Class II | 2019-10-03 |
| K191066 | CD Horizon Astute Spinal System | Medtronic Sofamor Danek USA, Inc. | NQP | Class II | 2019-10-03 |
| K191344 | Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module | Arthrex, Inc. | HRS | Class II | 2019-10-03 |
| K191932 | Momentum Posterior Spinal Fixation System | Ulrich Medical USA | NKB | Class II | 2019-10-02 |
| K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System | Zimmer GmbH | LZO | Class II | 2019-10-01 |
| K191848 | APTUS Wrist Spanning Plates 2.5 | Medartis AG | HRS | Class II | 2019-09-30 |
| K191074 | Sorrento Bone Graft Substitute | Xenco Medical, LLC | MQV | Class II | 2019-09-27 |
| K192352 | MiniMAX | Medacta International S.A. | LZO | Class II | 2019-09-27 |
| K191336 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2019-09-26 |
| K191748 | Genesys Spine Sacroiliac Joint Fusion System | Genesys Spine | OUR | Class II | 2019-09-26 |
| K191537 | eCarbon IBDs | Back 2 Basics Direct, LLC | ODP | Class II | 2019-09-26 |
| K191765 | OMNI TiN Coated Apex Knee System | Omni Life Science, Inc. | JWH | Class II | 2019-09-25 |
| K191791 | TranS1 Interbody Fusion System | Trans1 | MAX | Class II | 2019-09-25 |
| K192354 | Innovasis Gibralt Spine System | Innovasis, Inc. | NKG | Class II | 2019-09-24 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System | Medos International SARL | PGM | Class II | 2019-09-24 |
| K190483 | SPIRA Open Matrix ALIF and LLIF | Camber Spine Technologies | MAX | Class II | 2019-09-23 |
| K190100 | USTAR II System | United Orthopedic Corporation | KRO | Class II | 2019-09-23 |
| K191927 | Hinged Laminoplasty System | Life Spine, Inc. | NQW | Class II | 2019-09-20 |
| K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics , Ltd. | PML | Class II | 2019-09-19 |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage | Solco Biomedical Co., Ltd. | MAX | Class II | 2019-09-18 |
| K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | MAX | Class II | 2019-09-18 |
| K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | KWY | Class II | 2019-09-17 |
| K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | ODP | Class II | 2019-09-17 |
| K191576 | Mercury® Spinal System, Overwatch® Spinal System | Spinal Elements, Inc. | NKB | Class II | 2019-09-16 |
| K191641 | AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws | Industrias Medicas Sampedro S.A.S | HRS | Class II | 2019-09-16 |
| K190708 | AccelFix Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | MAX | Class II | 2019-09-16 |
| K190830 | TDM Screw Systems | Tdm Co., Ltd. | HWC | Class II | 2019-09-13 |
| K191459 | JuggerStitch Meniscal Repair Device | Biomet, Inc. | MBI | Class II | 2019-09-13 |
| K192217 | NCB Plating System Distal Femur and Proximal Tibia | Zimmer GmbH | HRS | Class II | 2019-09-13 |
| K190288 | Arthrex Tenodesis Button | Arthrex, Inc. | MBI | Class II | 2019-09-13 |
| K191726 | mont blanc & mont blanc MIS Spinal Systems | Spineway SA | NKB | Class II | 2019-09-12 |
| K191300 | MectaLock Ti Suture Anchor | Medacta International S.A. | MBI | Class II | 2019-09-12 |
| K191516 | Ali Interbody Fusion System | Raed M. Ali, M.D., Inc. | MAX | Class II | 2019-09-12 |
| K190398 | Republic Spine Restore Intervertebral Body Fusion System | Republic Spine, LLC | MAX | Class II | 2019-09-12 |
| K191148 | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | PML | Class II | 2019-09-12 |
| K191811 | Catalyst OrthoScience CSR Shoulder System | Catalyst Orthoscience, Inc. | KWT | Class II | 2019-09-11 |
| K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | ODP | Class II | 2019-09-09 |
| K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | HSB | Class II | 2019-09-06 |
| K192148 | Freedom Primary PCK | Maxx Orthopedics, Inc. | JWH | Class II | 2019-09-05 |
| K191625 | Persona Revision Knee System | Zimmer, Inc. | JWH | Class II | 2019-09-05 |
| K192155 | Smith & Nephew DYONICS 25 Fluid Management System | Smith & Nephew, Inc. | HRX | Class II | 2019-09-04 |
| K192156 | Cartiva SCI instrumentation set | Cartiva, Inc. | QBO | Class II | 2019-09-04 |
| K191500 | NuVasive® ACP System | Nu Vasive, Incorporated | KWQ | Class II | 2019-09-03 |
| K191617 | Syntec Tibial Nail System | Syntec Scientific Corporation | HSB | Class II | 2019-09-03 |
| K192071 | iNSitu Total Hip System | Theken Companies, LLC | LPH | Class II | 2019-08-30 |
| K191786 | Cyclops Anterior Cervical Plate System | Degen Medical, Inc. | KWQ | Class II | 2019-08-30 |
| K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | QHE | Class II | 2019-08-30 |
| K183407 | Triton Cage | Medyssey USA, Inc. | MAX | Class II | 2019-08-30 |
| K191319 | Dunamis Fixation Button System | Dunamis, LLC | MBI | Class II | 2019-08-29 |
| K192054 | Endoskeleton TAS Plate | Titan Spine, Inc. | OVD | Class II | 2019-08-29 |
| K192076 | Binary® Anterior Cervical Plate System | Genesys Spine | KWQ | Class II | 2019-08-29 |
| K191399 | BIOLOX CONTOURA Ceramic Femoral Head | Total Joint Othopedics, Inc. | LZO | Class II | 2019-08-28 |
| K191810 | Curiteva Pedicle Screw System | Curiteva, Inc. | NKB | Class II | 2019-08-28 |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics | JDI | Class II | 2019-08-28 |
| K191778 | Omnia Medical VBR | Omnia Medical, LLC | PLR | Class II | 2019-08-28 |
| K191569 | Implantcast ic-Bipolar Head System | Implantcast GmbH | KWY | Class II | 2019-08-28 |
| K190704 | Signature Ceramic Femoral Head | Signature Orthopaedics Pty, Ltd. | LZO | Class II | 2019-08-28 |
| K191424 | Interphalangeal Joint Fusion Device Range | Neosteo | HWC | Class II | 2019-08-28 |
| K190904 | Conformis BeneFIT Hip System | Conformis, Inc. | LPH | Class II | 2019-08-28 |
| K183684 | Libertas Taper Uncemented Femoral Stem | Maxx Orthopedics, Inc. | LZO | Class II | 2019-08-23 |
| K192047 | Rampart One Lumbar Interbody Fusion System | Spineology, Inc. | OVD | Class II | 2019-08-23 |
| K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Stryker GmbH | HRS | Class II | 2019-08-23 |
17,115 clearances in the Orthopedic panel. Data: openFDA.